Accord BioPharma's DMB-3115 Secures USFDA Approval

The biosimilar DMB-3115 stands as a potential substitute for STELARA®, a widely used drug for treating plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. STELARA® is one of the leading biologics with market sales up to $13.9 billion in 2022.

Intas Pharma’s wholly-owned subsidiary, Accord BioPharma has received US Food and Drug Administration's (USFDA) approval for its Biologics Licence Application (BLA) for DMB-3115.

The biosimilar DMB-3115 stands as a potential substitute for STELARA®, a widely-used drug for treating plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. STELARA® is one of the leading biologics with market sales up to $13.9 billion in 2022.

Chrys Kokino, president, Accord BioPharma, highlighted the potential impact of DMB-3115 on patient experiences, emphasising the established efficacy of its reference product, STELARA, in addressing autoimmune diseases.

Kokino said, "Our mission to go beyond the biology of medicine includes seeking to ease the financial burden for patients and the U.S. healthcare system by providing medicines that may be more affordable, such as biosimilars."

The journey of DMB-3115 traces back to joint development efforts initiated in 2013 by South Korea’s Dong-A Socio Holdings and Japan’s Meiji Seika Pharma. In this partnership, exclusive commercialisation rights were granted to Intas Pharmaceuticals in the year 2021. As per the agreement, its global subsidiary, Accord is responsible for the commercialisation of DMB-3115 in the US.

On the partnership, Binish Chudgar, VC & MD, Intas Pharmaceuticals, said, "Our partnership with Dong-A Socio Holdings and Meiji Seika Pharma reinforces our long-term commitment towards improving access to world-class biosimilar drugs for patients globally.’’

As Accord BioPharma received the approval of DMB-3115's BLA, the company anticipates additional regulatory milestones. Three separate BLAs for biosimilar versions of trastuzumab, pegfilgrastim, and filgrastim have also been submitted to the FDA.

Over the next five years, Accord BioPharma is poised to introduce several additional biosimilars to the US market, signalling a commitment to expanding accessible and cost-effective healthcare options.

Founded in 1977 by Hasmukh Chudgar, Intas Pharma aims to provide high-quality medicines at affordable prices to patients with various diseases such as CNS, Cardio, Diabeto, Gastro, Urology, and Oncology. It also focuses on developing and manufacturing biosimilar products based on recombinant DNA and monoclonal antibodies.

Days back, Intas Pharma collaborated with mAbxience for Etanercept Biosimilar. With this new partnership, Intas and mAbxience are poised to make a lasting impact on the lives of millions affected by autoimmune diseases while also strengthening Intas' leadership in the global biosimilar landscape.